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headhunter推荐某外资CRO公司(北京)诚聘Principal Statistician
名额:1名
工作地点:北京大望路
要求:海归背景
待遇:市场价格(不便张扬)
Job Description
Job Specifications
Job Title: Principal Statistician
Department: Statistics and Pharmacokinetics
Location: Beijing
Reports to: Manager or above
The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.
I. Job Summary:
A. Duties and Responsibilities:
• Supervision of less-experienced statisticians within project activities
• Statistical/Biometrics lead for large global or other major programs.
• Provide statistical input into other disciplines’ activities and participate in interdepartmental processes.
• Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
• Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups.
• Responsible for Biostatistics’ deliverables within assigned projects.
• Develop and coordinate QC procedures for Biometrics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within a specific project.
• Statistical analysis of clinical trial data and related decision making.
• Responsible for statistical input to statistical reports and Clinical Study Reports. Authorizes final reports as one of Covance signatories.
• Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signatory.
• Provide statistical input into design/review of format of CRFs.
• Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding information.
• Independent peer review of statistical deliverables, eg, protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
• SAS programming and related activities for the presentation and analysis of clinical trial data.
• Contribution to review and amendment of departmental processes and supporting documentation.
• Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
• Provide support for special committees, eg, DMCs, including input/review of charters, and ensuring maintenance of appropriate blinding.
• Contribute to proposal activities and client presentations.
• Represent the department during audits.
• Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
• Perform other duties as requested by management.
B. Language Skills Required:
• Speaking: Yes English/Mandarin if located in China
• Writing/Reading: Yes English/Mandarin if located in China
II. Education/Qualifications:
Required:
An MSc or PhD in a statistics subject, preferably with a strong medical statistics component.
(Alternative academic qualifications are assessed for comparability.)
III. Experience:
Required:
Approximately 5.5 years’ postgraduate experience in the application of statistics to clinical trials.
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